What is an Audit or Survey?An Audit or survey is the on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. Audits are an independent and unbiased evaluation of your existing practices to determine if a business complies with policies, contract commitments and regulatory standards. An audit can apply to an entire organization or might be specific to a function, process, or production step. Reasons for auditing include evaluation of your competitive edge, pre-audit assessment, and continuous improvement.
Results of quality assurance audits or surveys are used to identify problems, reduce costs, assess personnel competency, review equipment maintenance programs, provide visible management support, ensure adherence to process standards, determine system effectiveness, and identify system inefficiencies.
Contact us to learn more or to schedule your quality assurance auditor.
SafeLink consultants can perform the following types of audits:
- Quality System Internal Audit – This audit is an independent and unbiased evaluation of your existing quality program to establish conformance with the FDA Good Manufacturing Practices. FDA requires that establishments periodically perform an Internal Audit to show that compliance standards are being met. The audit verifies that the Quality System has been correctly communicated and is practiced. The audit is typically followed up with a written Audit Report that indicates any non-conformances. It is strongly recommended that 2-3 months prior to a third-party audit, an internal audit be performed.
- Second Party Audit – This audit is performed if you need to have suppliers or subcontractors audited before establishing a relationship.
- Third Party Audit – This audit is performed for certification to a recognized standard, such as ISO. It is strongly recommended that 2-3 months prior to a third-party audit, an internal audit be performed. The internal audit results and corrective actions would typically be taken into consideration by the third-party auditor in their decision for FDA compliance, and/or ISO registration.
- Process Survey – Assesses the performance of processes and gathers information and insight for improving processes.
- Product Audit – Focuses on a specific product provided by the facility or company.
- Operational Audit – Concentrates on organizational activities.
- Readiness Survey – Determines conformance status prior to a certification or regulatory audit.
- Due Diligence – Third-party evaluation of legal requirements regarding FDA, OSHA, and other applicable states, federal and international requirements being met for a business you may be purchasing or selling.
For more information on SafeLink’s audits and surveys, please contact us today.
Learn more about how SafeLink Consulting can assist your business with FDA compliance.